MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number FR8A-RCV-A0, FR8A-SPR-B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

The implanting clinician had discussed with the patient the possibility of removing the stimulator.The clinical representative asked the implanting clinician to seek guidance from stimwave cmo on the occurrence.The cmo and the implanting clinician discussed the event.They determined that the wound not healing might be related to a reaction to the silk stitches or pocket being too superficial.The implanting clinician and the cmo decided to perform a pocket revision to aid with the wound healing.On (b)(6) 2021, the implanting clinician performed the pocket revision and prescribed antibiotics for ten days (name and dosage unknown).The patient was instructed to follow-up with the implanting clinician in ten days as long as no medical emergency occurs.The clinical representative confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant a stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Based on this information, the wound not healing was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the wound not healing is due to a reaction to the silk stitches or pocket being too superficial.

Event Description

On (b)(6) 2021, the clinical representative became aware that a recently implanted patient wound was not healing and closing.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11536990
• MDR Text Key: 241381495
• Report Number: 3010676138-2021-00050
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2022
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO200605, SWO200305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention